{"publicDeviceRecordKey":"5d8dc801-52e5-457b-aa1b-2852c9d08481","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-09-18T00:00:00.000Z","devicePublishDate":"2021-10-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B971DM80","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"B971DM81","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DentalMark","versionModelNumber":"DentalMark 2.0mm flat fiducial markers","catalogNumber":null,"dunsNumber":"055127831","companyName":"Jessop Precision Products Inc.","deviceCount":110,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"800-406-3399","phoneExtension":null,"email":"orders@suremark.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63530","gmdnPTName":"Dental guided surgery registration/navigation spatial marker","gmdnPTDefinition":"A non-powered device designed to be attached to the patient’s tooth/teeth to mark the location where a dental procedure (e.g., drilling, implant placement) is to occur during guided dental implantation surgery. It is intended to remain in situ during the preoperative patient registration chairside cone beam computerized tomography (CBCT) scan, and during the dental procedure, to assist with intraoperative navigation (e.g., using optical tracking). Also referred as a navigation fiducial marker, it is made of plastic and radiopaque materials and is attached via dental impression. This is a single-patient device which may be reattached to the patient during the procedure before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JAC","productCodeName":"System, X-Ray, Film Marking, Radiographic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}